NEHI’s Valerie Fleishman on Cost Effectiveness Research (transcript)

This is the transcript of my recent podcast interview with NEHI Executive Director Valerie Fleishman.

David Williams:            This is David E. Williams, co-founder of MedPharma Partners and author of the Health Business blog.  I’m speaking today with Valerie Fleishman.  She is Executive Director of the New England Health Care Institute sometimes known as NEHI.  NEHI recently released an issue brief called From Evidence to Practice, Making Comparative Effectiveness Research Findings Work for Providers and Patients and we’ll be talking about that today.  Valerie, it’s nice to have you with me.

Valerie Fleishman:            Thanks David.

Williams:            Before we dig into the details, can you explain what comparative effectiveness research (CER) is?

Fleishman:            At its most basic level, comparative effectiveness research is about finding out what works in medicine and health care.  Its fundamental goal is to assist consumers, patients, clinicians and others to make more informed decisions at the point of care. The new federally funded comparative effectiveness research is set up to look at very broad areas of the health care system.  It’s set up to compare different drugs, to compare different medical devices, tests, surgeries or even whole ways of delivering health care.

Williams:            You alluded to the fact that there are some provisions on comparative effectiveness research in the Affordable Care Act (ACA).  How does the Affordable Care Act address comparative effectiveness?

Fleishman:            Comparative effectiveness research was first established as part of the Recovery Act in 2009 as part of the stimulus legislation. That legislation had in it a $1.1 billion investment for comparative effectiveness research and laid the foundation for what appeared in the Affordable Care Act in March. There are several relevant provisions in the Affordable Care Act:

One, it establishes a non-profit corporation called the Patient Centered Outcomes Research Institute (PCORI).  That institute is set up as a non-governmental, private entity to oversee the federally funded investment that we’re making in comparative effectiveness research. The ACA says that the institute will identify priorities for comparative effectiveness research, will help to carry out the research agenda, create advisory panels, establish peer review processes, and will also in part be responsible for releasing the research findings and coordinating the research that gets done.

Another ACA provision –and something discussed in all debates on CER– is the importance of transparency and patient protections.  Transparency includes how the research is done, what the methodologies are used and what the results are.

On the patient protection side there have been concerns about how well comparative effectiveness research will identify outcomes in different sub populations.  So a provision in ACA specifies that comparative effectiveness research must take into account different subpopulations to avoid one-size-fits-all results.

It also talks about how none of the reports or findings can be used as mandates, guidelines or policy recommendations and that the findings cannot be used as sole evidence in making determination decisions.

Third, it sets up really a trust fund so comparative effectiveness research can be funded on an ongoing basis. The $1.1 billion put in as part of the stimulus was really just for the first couple of years. The trust fund creates a pool of funding of about $600 million per year from both the Medicare trust and a fee on health plans.

Williams:            What impact will patients and physicians feel at the point of care? How soon we might see some impact?

Fleishman:            Great question.  It’s certainly going to take a while. If history is any guide, unless we really change how we get this information into patients’ and clinicians’ hands faster it, in many cases will take a long time.  The IOM has shown that it can take as many as 17 years to get evidence based medicine into clinical practice. Frankly today, even under the best of circumstances, it’s virtually impossible for patients –unless they’re reading The New England Journal of Medicine or JAMA or certain Internet resources– to get access to the best clinical information, particularly in a way that’s digestible.

Williams:            There’s a lot of controversy about the use of comparative effectiveness research and whether it’s actually some kind of a code for rationing or other things that would be negative for the patient.

Fleishman:            That certainly was the focus during the initial debate on comparative effectiveness research when it was part of or being considered as part of the stimulus bill. I think there are some valid concerns. There has been a fair bit of backlash against  the terminology or the concept of evidence based medicine. People fear that it might mean cookbook medicine; that my doctor won’t be able to select the right treatment for me but will give me what works for everybody else, which may not be the best decision for me.

Second, there is this concern based on what we’ve seen it happen in other countries that comparative effectiveness research could be used for cost reduction purposes and rationing.  That has been part of the debate.  It’s why this $1.1 billion in the stimulus bill probably got more attention than almost anything else in the legislation even though it was a tiny, tiny fraction of the total investment in the bill. That’s why in the legislation establishing the Patient Centered Outcomes Research Institute there has been very explicit language that these studies cannot be used to change Medicare decisions.

Williams:            You talked earlier about the IOM findings about how long dissemination of new information takes in the medical profession. Are any things in place now that might accelerate that adoption? In particular what about health information technology?

Fleishman:            There is an enormous opportunity, particularly when you look at the definition of meaningful use and you think about the computerized physician order entry systems and others that will be part of this. Meaningful use clearly stipulates that these systems have to have some form of clinical decision support. One of the hurdles to adoption for CER is that clinicians themselves don’t have ready access to the latest information on what the evidence says about different forms of treatments or procedures. Providing the information technology infrastructure and tools to clinicians at the point of care so they can have access to the data will go a long way toward making the data accessible.

But technology is really only one of the hurdles. Even if physicians have access to the data, it may not necessarily change behavior.

Williams:            I’ve been speaking today with Valerie Fleishman, Executive Director of the New England Health Care Institute about comparative effectiveness research.  Valerie, thanks for your time today.

Fleishman:            Thanks so much David.

October 13, 2010

One thought on “NEHI’s Valerie Fleishman on Cost Effectiveness Research (transcript)”

  1. if CER is to use EMR data, then pharma should be permitted to drop phase 4 studies and use the same data for their postmarket surveillance.

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